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NCT05836324PHASE1Recruiting

A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

Incyte Corporation

Start Date

7/24/2023

Completion Date

5/3/2029

Summary

To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * ≥18 years old * Histologically or cytologically confirmed advanced or metastatic malignancies as defined in the protocol. * Part 1: Participants must have experienced disease progression after treatment with, be intolerant to, or be ineligible for, or refused available therapies, including anti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinical benefit. Part 2: depending on cohort, participants may have received or not prior treatment for the malignancy under study. * ECOG performance status score of 0 or 1. * Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional). Biopsies are mandatory depending on the cohorts. * Presence of measurable disease according to RECIST v1.1. Exclusion Criteria: * Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years. * Not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy. * Has active autoimmune disease requiring systemic immunosuppression with corticosteroids. * Brain or CNS metastases untreated or that have progressed. * History of organ transplant, including allogeneic stem cell transplantation. * History of clinically significant or uncontrolled cardiac disease. * Active HBV, active HCV, or HIV positive. * Is on chronic systemic steroids (\> 10 mg/day of prednisone or equivalent). * Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment * Participants that have been initiated on or had modifications in anticoagulation therapies within the last 3 months prior to first dose of treatment. * Significant concurrent, uncontrolled medical condition, eg: * Cardiovascular: Participants with known vasculitis, aneurisms, and other vascular malformations of clinical significance or history of myocarditis. * Gastrointestinal: Any bowel obstruction within 60 days prior to C1D1. * Participants with adequate laboratory values within the protocol defined ranges. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Interventions

DRUG

INCA33890

DRUG

bevacizumab

DRUG

FOLFIRI

DRUG

FOLFOX

DRUG

Cetuximab

DRUG

ADG126

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Conditions

Solid TumorsAdvanced Solid TumorsMetastatic Solid Tumors

Locations

The Angeles Clinic and Research Institute

Los Angeles, California 90025

United States

Valkyrie Clinical Trials

Los Angeles, California 90067

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

Cancer and Hematology Centers of Western Michigan-Start Midwest

Grand Rapids, Michigan 49546

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Nyu Langone Health - Long Island Hospital

Mineola, New York 11501

United States

Laura and Isaac Perlmutter Cancer Center

New York, New York 10016

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Lifespan Cancer Research Institute

Providence, Rhode Island 02903

United States

University of Texas Md Anderson Cancer Center

Houston, Texas 77030

United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas 78229

United States

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, 100021

China

Peking University People'S Hospital

Beijing, 100044

China

The First Affiliated Hospital, Zhejiang University School of Medicine (Fahzu)

Hangzhou, 310003

China

Rigshospitalet Uni of Hospital of Copenhagen

Copenhagen, 02100

Denmark

Herlev Og Gentofte Hospital

Herlev, 02730

Denmark

Odense University Hospital

Odense C, 05000

Denmark

Vejle Hospital

Vejle, 07100

Denmark

Centre Leon Berard

Lyon, 69373

France

Institut Gustave Roussy

Villejuif, 94805

France

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, 20133

Italy

Irccs Istituto Clinico Humanitas

Rozzano, 20089

Italy

Centro Ricerche Cliniche Di Verona

Verona, 37134

Italy

Kansai Medical University Hospital

Hirakata, 573-1191

Japan

National Cancer Center Hospital

Tokyo, 104-0045

Japan

The Cancer Institute Hospital of Jfcr

Tokyo, 135-0063

Japan

Start Barcelona

Barcelona, 08023

Spain

Hospital General Universitario Vall D Hebron

Barcelona, 08035

Spain

Fundacion Jimenez Diaz University Hospital

Madrid, 28040

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Centro Integral Oncologico Clara Campal

Madrid, 28050

Spain

Istituto Oncologico Della Svizzera Italiana

Bellinzona, 06500

Switzerland

Centre Hospitalier Universitaire Vaudois (Chuv)

Lausanne, 01011

Switzerland

Kantonsspital St. Gallen

Sankt Gallen, 09007

Switzerland

Cambridge University Hospitals Nhs Foundation Trust

Cambridge, CB2 0QQ

United Kingdom

Guys and St Thomas Nhs Foundation Trust

London, SE1 9RT

United Kingdom

Imperial College Healthcare Nhs Trust - Hammersmith Hospital

London, W12 0HS

United Kingdom

The Christie Nhs Foundation Trust Uk

Manchester, M20 4BV

United Kingdom

Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust

Newcastle upon Tyne, NE7 7DN

United Kingdom